The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss current strategies and trends to accelerate promising molecules from research to commercialization.
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8th Asia Tides Feb 2016, Kyoto, Japan
1. IBC’s 8th Annual
Register Early and Save Up to USD400! www.IBCLifeSciences.com/AsiaTIDES
February 24-26, 2016 • Westin Miyako Kyoto • Kyoto, Japan
The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss
current strategies and trends to accelerate promising molecules from research to commercialization
世界中のオリゴヌクレオチドとペプチドのグローバルリーダー達が一堂に会するアジア唯一のイベン
トで、前途有望な分子の研究から商業化までを加速するために、現在の戦略と傾向を話し合います。
Duchenne Muscular Dystrophy
Once-Weekly Peptide: Semaglutide
Challenge to be a Global
Pharma Innovator
Exon-skipping Therapies
Constrained Peptides and
Peptide-Based Drug Design
Locked Nucleic Acids
Global Experts Help Accelerate Your Molecules to Market
Joji Nakayama
Daiichi Sankyo, Japan
Masafumi Matsuo, M.D., Ph.D.
Kobe Gakuin University, Japan
Keiichi Masuya, Ph.D.
PeptiDream Inc., Japan
Troels Koch, Ph.D.
Roche Innovation Center
Copenhagen, Denmark
Shin'ichiTakeda, M.D., Ph.D.
National Center of Neurology
and Psychiatry, Japan
Jesper Lau, Ph.D.
Novo Nordisk A/S, Denmark
Media Parters: Organized by:
n Optimize the drug-like properties of your molecule for accelerated approval
• Phase 2/3 case studies • Delivery/formulation • Conjugates • Novel discoveries
n Discover CMC techniques and analytical strategies for complex molecules
• Large & small scale • Cost reduction • Novel synthesis • Lifecycle management
n Reach new markets & find partners for your molecules, technologies and services
•Innovation & investment landscape • Regulatory perspectives • Networking dinner
2. Dear Colleagues:
AsiaTIDES is Asia-Pacific’s leading oligonucleotide and peptide
therapeutics event for discovery, clinical and CMC scientists to share
best practices and success factors to help you accelerate molecules
from research to commercialization. The international speaker faculty
represents companies from the US, Europe, Japan, Australia and APAC
and provides a comprehensive update on the global progress of
oligonucleotides and peptides in development, so you can benchmark
your own programs and find new ideas to improve the development
of your products.
In response to your requests, this year’s program includes more
preclinical and clinical case studies than ever before from industry
bellwether companies including:
• Isis Pharmaceuticals
• Alnylam
• Novo Nordisk
• Roche
• Daiichi Sankyo
• Polyphor
• Sarepta Therapeutics
• CanBas
• Dicerna
• PeptiDream
• Noxxon
• miRagen Therapeutics
• Zealand Pharma
• and many more….
I encourage you to register today and maximize the value of attending
AsiaTIDES in Kyoto by participating in these additional activities:
• Share and find new research in the poster sessions
• Evaluate new products and services in the exhibit hall
• Find collaborators during the networking breaks, lunches,
networking dinner and cocktails
• Take an extra day to explore the historic and beautiful city of Kyoto
Sincerely,
Michael P. Keenan
Project Manager and Producer
Your International AsiaTIDES Advisory Committee
Robert Hagopian, Director Business Development, PolyPeptide Laboratories, USA
Yusuke Kohno, Vice President, Jitsubo Co Limited, Japan
Shawn Lee, Ph.D., President and CEO, CPC Scientific, USA and China
Dong-ki Lee, Ph.D., Professor, Sungkyunkwan University and CEO Founder, OliX
Pharmaceuticals, Korea
Patrick Lu, Ph.D., Founder, President and CEO, Sirnaomics, Inc., USA
Michael McGinley, Manager, Core Products, Phenomenex, USA
Bruce Morimoto, Ph.D., Executive Director Applied Translational, Medicine, Drug
Development Services, Celerion, USA
El Djouhar Rekaï, Head of Peptide Products Operation, Lonza, Belgium
Hideaki Sato, General Manager, Technical Support and Marketing, GeneDesign, Inc.,
Japan
Osamu Sato, Executive Director, RD Planning Department, Daiichi Sankyo, Japan
Dmitry Samarsky, Ph.D., SVP, International Business and Technology Development,
RiboBio, China
G. Susan Srivatsa, Ph.D., President, ElixinPharma, USA
Daisuke Takahashi, Ph.D., Manager, Bio-functional Molecular Chemistry Group,
Research Institute for Bioscience Products Fine Chemicals, Ajinomoto Co., Inc.,
Japan
2 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg
Accelerate Your Oligo and Peptide Molecules to Market
Meet the People Behind the Products and Get
the AnswersYou Need
The AsiaTIDES Exhibit Hall will give you the opportunity to find the
technologies and services you need to accelerate research, discovery
efforts and clinical programs. Visit vendor booths to discuss new product
advancements, network with industry and academic researchers, engineers
and executives during scheduled luncheons and receptions, or spend time
at the popular and innovative Poster Sessions. See more details on page 7.
Call for Posters
Limited space is available for poster presentations at this event.
If you have new results/data on topics relevant to this conference, we
encourage you to submit a poster abstract for consideration.
To present a poster, complete the conference registration form and
submit poster title and one page poster abstract online at
www.IBCLifeSciences.com/AsiaTIDES by January 27, 2016.
See registration form for poster fees.
The Westin Miyako Kyoto
1 Awataguchi Kachocho, Higashiyama-ku, Kyoto 605-0052, Japan
Tel: +81-75-771-7111 • Fax: +81-75-751-2490
Website: http://www.miyakohotels.ne.jp/westinkyoto/english/index.html/
Special Room Rates for AsiaTIDES Attendees:
JPY 19440/JPY 21600 (Superior Single/Twin) •JPY 25960/JPY 28080 (Deluxe Single/Twin)
To book a room at the Westin Miyako Hotel at the special AsiaTIDES group rate, please
reserve your room by visiting the hotel section at www.IBCLifeSciences.com/AsiaTIDES
3. Main Conference • Concurrent Tracks Wednesday, February 24, 2016
Oligonucleotides in Preclinical and
Clinical Development
11:00 Chairman’s Remarks
Karsten Schmidt, Ph.D., Senior Scientist, Structural Biology, Isis Pharmaceuticals, USA
11:15 Stabilization and Activation of Double-stranded Nucleic
Acid Drugs by Artificial Cationic Molecules
We have developed novel cationic oligosaccharides and cationic peptides that
selectively bind to A-type RNA/RNA and DNA/RNA duplexes. In this presentation,
I would like to describe the synthesis and properties of these unique molecules
as carriers and stabilizers of siRNA drugs and antisense DNA/RNA heteroduplexes.
Takeshi Wada, Ph.D., Professor, Department of Medicinal and Life Science,
Faculty of Pharmaceutical Sciences, Tokyo University of Science, Japan
11:45 Defining the Relationship between ASGR Binding and
Activity for GalNAc-ASO Conjugates
A fluorescence polarization competition assay was established to determine
the influence of GalNAc valency, ASO length, backbone composition and
charge on ASGR binding. Results gained from this approach were correlated
to ASO activity in hepatocytes and mice. Our work provides insights into the
interactions of ASO-conjugates with cell-surface receptors and on functional
uptake of ASOs into cells and tissues.
Karsten Schmidt, Ph.D., Senior Scientist, Structural Biology, Isis Pharmaceuticals, USA
12:15 Networking Luncheon with Exhibit and Poster Viewing
1:30 Presentation Sponsorship Opportunity
For more information about sponsoring a drug development case study,
application or technology presentation in this session, please contact
Patrick Gallagher at pgallagher@ibcusa.com.
2:00 PreclinicalTherapeutic Development againstTopical
Diseases Using Cell Penetrating, Asymmetric RNAiTriggers
Cell penetrating, asymmetric siRNA (cp-asiRNA) is an asymmetric RNAi trigger
with simple combination of chemical modifications. cp-asiRNA enters into cells
and triggers target gene silencing via RNA interference without the need of
delivery vehicle. Preclinical therapeutic development against skin, eye and lung
diseases using cp-asiRNA platform will be presented.
Dong-ki Lee, Ph.D., Professor, Sungkyunkwan University and Founder and
CEO, OliX Pharmaceuticals, Korea
Featured Presentation
2:30 Activity Determinants of Locked
Nucleic Acids
Small structural modifications of antisense oligonucleotides
can have significant effects on structure/activity relations. The
underlying nature of these subtle relationships cannot be
understood from a reductionist view point. We have employed
a new modelling strategy to get a better understanding on how
the structural units can impact the properties of LNA.
It will be presented how new chemical modifications and designs can improve
central therapeutic parameters of LNA.
Troels Koch, Ph.D., VP Head of Research, RNA Therapeutics,
Roche Innovation Center Copenhagen, Denmark
3:00 Networking Refreshment Break with Exhibit and Poster Viewing
Peptide Discovery
11:00 Chairman’s Remarks
Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine,
Drug Development Services, Celerion, USA
11:15 Oral Equivalents of Monoclonal Antibodies:
Exploitation of Constrained Peptides
This presentation will briefly describe platform technology and focus on
optimization of the oral delivery of constrained peptides, that are alternatives
to marketed antibodies Stelara and Entyvio, for treatment of IBD. The
presentation will describe rodent and monkey data, and criteria for selection
of IND candidates which should enter the clinic in 2015 and early 2016.
Mark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutics,
Australia
11:45 Presentation Title TBA
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Speaker TBA, Waters
12:15 Networking Luncheon with Exhibit and Poster Viewing
Drug Delivery Strategies for Peptides
1:30 Delivery Strategies for Peptides in Clinical Development
This presentation will include a brief overview of technologies available for
subcutaneous injection replacement, injectable sustained release formulation,
half-life extension and non-invasive delivery. The challenges and opportunities
for each of these approaches will be clarified. In addition, a pathway for clinical
development of a new peptide will be discussed along with strategy and
timing for incorporating life cycle options.
Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts, USA
2:00 Peptide Mediated Delivery of Bioactive Proteins into Cells
Numerous approaches have been reported up to the present time for
intracellular delivery. However, approaches are still needed that have improved
efficacy in delivering high-molecular-weight proteins into cytosol to obtain
enhanced bioactivity. By modifying sequences of natural hemolytic peptides,
we have succeeded in creating a peptide, which has a low cytotoxicity but has
a high ability to yield a marked cytosolic release of endocytosed proteins.
Shiroh Futaki, Ph.D., Professor, Institute for Chemical Research,
Kyoto University, Japan
2:30 Biodegradable Silica Based Delivery of
Therapeutic Peptides
Biodegradable silica is a powerful drug delivery matrix for sustained release of
parenteral therapeutics. Encapsulation of peptides in nanoporous silica provides an
effective tool to administer peptides in a controlled manner even for several months.
The presentation describes the basics of silica technology with several case studies.
Lasse Leino, Ph.D., Adjunct Professor and CEO, DelSiTech Ltd., Finland
3:00 Networking Refreshment Break with Exhibit and Poster Viewing
Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 3
Main Conference • Plenary Session Wednesday, February 24, 2016
Keynote Presentation
9:15 Therapeutic Approaches to Duchenne
Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is the most common
childhood genetic disease, affecting one in 3,500 newborn boys,
causing progressive muscle weakness, heart and respiratory
failure and premature death. This disease is caused by the
mutations of the DMD gene, and no cure exists for this disease, but a number
of promising new molecular therapies are being intensively studied. Among
them, exon skipping by antisense oligonucleotides is a novel method to
restore the reading frame of the mutated DMD gene, and rescue dystrophin
expression. I will present the recent progress of therapy of the disease.
Shin'ichi Takeda, M.D., Ph.D., Director General, National Institute of
Neuroscience, National Center of Neurology and Psychiatry, Japan
Keynote Presentation
9:45 Paradigm Shift in Drug Discovery:
Constrained Peptides and
Peptide-Based Drug Design
Constrained peptides represent highly valuable chemical
matter for use in biological validation, identifying hit/lead
molecules for drug discovery, and also directly as peptide
therapeutics. Our in-house approach to the optimization of constrained
peptides, and how these peptides contribute to hit finding for difficult target
classes from a general perspective will be introduced.
Keiichi Masuya, Ph.D., Chief Operating Officer, PeptiDream, Inc., Japan
8:15 Registration and Coffee
9:10 Chairman’s Remarks Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd, Australia
10:15 Networking Refreshment Break with Exhibit and Poster Viewing
4. Main Conference • Concurrent Tracks Wednesday, February 24, 2016(continued)
4 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg
3:45 Daiichi-Sankyo’s Strategies and Experiences in Biologics
focused Oligonucleotide Drug Development
This presentation will discuss Daiichi-Sankyo’s progress in the development of
biologics especially oligonucleotide drugs. Lessons learned to date, technical
challenges experienced and future approaches to progress our oligonucleotides
drugs as an important part of our biologics pipeline will be presented.
Junichi Koga, Ph.D., Corporate Officer and Global Head of Biologics,
Daiichi Sankyo, Japan
4:15 ALN-HBV, An Investigational RNAi Drug for the
Treatment of Chronic Hepatitis B
Chronic hepatitis B infection is a serious liver disease impacting 400 million
people worldwide. Clinical manifestations are severe, and an estimated 1
million people die each year from the disease and its complications. With
today’s medicines, the cure rate for chronic HBV infection is less than 10%.
An RNAi therapeutic inhibiting all steps of the HBV life cycle and silencing
tolerogenic viral antigens has the potential to achieve a“functional cure.”
Laura Sepp-Lorenzino, Ph.D., Vice President, Entrepreneur-in-Residence,
Alnylam Pharmaceuticals, USA
4:45 Eteplirsen a Drug for Duchenne Muscular Dystrophy
DMD, a neuromuscular disease, affects ~1:3500 of newborn boys and
invariably leads to their untimely death. DMD is most commonly caused
by deletions in the DMD gene that disrupt the mRNA reading frame and
prevent translation of dystrophin, an essential muscle protein. In ongoing
trials, eteplirsen, a morpholino oligomer, has been shown to restore the mRNA
reading frame and induce production of dystrophin. This treatment led to
significant benefit in the six-minute walk test.
Ryszard Kole, Ph.D., Distinguished Scientist, Sarepta Therapeutics, USA
3:45 Phylomer Derived Cell Penetrating Peptides Facilitate
More Efficient Delivery of Peptides and Proteins to
the Cytoplasm
Phylomer peptide libraries have been screened for new cell penetrating peptides
for delivery of macromolecules and nanoparticles into cells. A novel genetic
screen known as the‘endosome escape trap’enables the isolation of rare CPP’s
which more efficiently deliver their cargoes to the cytoplasm. Some of these
cell penetrating Phylomers can be targeted to particular cell types. Phylogica has
developed a variety of functional assays to determine the extent of cytoplasmic
delivery of peptide and protein cargoes to the cytoplasm or nucleus. These
assays have shown Phylomer CPP’s to be 37-160 times more efficient than
TAT which can be active in vivo. These tools are now being applied in screens
targeting transcription factor oncoproteins such as cMyc NMyc and STAT5 as well
as for more efficient intracellular delivery of protein toxin conjugates.
Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd, Australia
4:15 An Improved Transdermal Patch of Teriparatide Using
Ionic Liquid Transdermal System (ILTS)
Teriparatide is a recombinant parathyroid hormone used in the treatment
of osteoporosis and approved as a subcutaneous injection. A transdermal
patch which delivers teriparatide is being developed using Ionic Liquid
Technology. A series of in vitro rat skin permeation tests and in vivo rat PK
studies have been conducted which led to selection of a formulation which
demonstrated a temporary increase in the concentration of teriparatide in the
blood. Additionally, dermal irritation tests confirmed that there was no dermal
irritation to the rat skin.
Tatsuro Moriyoshi, Researcher, RD Department, MEDRx Co. Ltd., Japan
Panel Discussion
4:45 Drug Delivery Systems and Strategies
Moderator: Bruce Morimoto, Ph.D., Executive Director Applied Translational
Medicine, Drug Development Services, Celerion, USA
5:15 Networking Reception in Exhibit and Poster Hall Co-sponsored by: and
Main Conference • Plenary Session Thursday, February 25, 2016
8:30 Registration and Coffee
8:55 Chairman’s Remarks
William S. Marshall, Ph.D., President and CEO, miRagen Therapeutics, USA
The Innovation and Investment Landscape
in Japan and China
9:00 The Japan Landscape of Investment and Innovation in
Oligonucleotide and Peptide Development
INCJ is a public-private investment fund which provides financial and
management support for next-generation businesses including innovative
drug development. This presentation will provide an overview of the
investment and innovation landscape in Japan as well as discuss the
future potential of and opportunities in oligonucleotide and peptide drug
development in Japan.
Koichi Ashida, Executive Managing Director, Innovation Network of
Japan, Japan
9:30 Development and Production of Therapeutic
Oligonucleotides in China
There is a growing interest towards oligonucleotide-based therapeutics among
drug developers in China. The field, however, still remains at relatively early
stages. This presentation will summarize current status of oligonucleotide
therapeutic programs. It will also outline the situation with the oligonucleotide
manufacturing capabilities in China. Finally, a summary of the recently introduced
by CFDA changes to the overall drug development process and procedures in
the country will be presented.
Dmitry Samarsky, Ph.D., SVP, International Business and Technology
Development, RiboBio, China
Keynote Presentation
10:00 Exon-skipping Therapy Advancing
Oligonucleotide Drug Development
This presentation will describe continued efforts in our laboratory
to exploit exon-skipping oligonucleotides to treat a variety of
diseases. Current progress and ongoing challenges of exon-
skipping will be discussed. An update on the learnings from
clinical studies in DMD patients will also be presented.
Masafumi Matsuo, M.D., Ph.D., Professor, Department of Medical Rehabilitation,
Kobe Gakuin University, Japan
10:30 Networking Refreshment Break with Exhibit and Poster Viewing
Oligonucleotides in Preclinical and
Clinical Development (continued)
Drug Delivery Strategies for Peptides (continued)
6:45 Networking Dinner in Kyoto
Join fellow attendees in a fantastic networking and dining opportunity at a
local restaurant in beautiful Kyoto. Space is limited and an additional fee applies.
Please indicate when you register if you plan to join the dinner.
5. Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 5
Main Conference • Concurrent Tracks Thursday, February 25, 2016(continued)
11:10 Chairperson’s Remarks
Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG,
Germany
11:15 Clinical Efficacy of AZD9150, a Next Generation,
Constrained Ethyl Modified Antisense Oligonucleotide
Inhibitor of STAT3 – Tumor Cell Autonomous and
Immuno-modulatory Activity
AZD9150 is a next generation ASO that has demonstrated robust single
agent efficacy in several tumor types in phase I clinical studies. Preclinical and
clinical data suggest the activity of AZD9150 is mediated by both tumor cell
autonomous effects as well as through modulation of the immunosuppressive
microenvironment through the inhibition of STAT3 in tumor-associated
immune cell populations.
A.Robert MacLeod, Ph.D., Vice President Oncology and Exploratory
Discovery, Isis Pharmaceuticals, USA
11:45 Mirror-image Oligonucleotide Aptamers Inhibiting the
Chemokine CXCL12/SDF-1 - From Identification to Phase
IIa Data
SDF-1/CXCL12 is a pro-angiogenic chemokine that plays a major role in
homing processes of stem cells and malignant stem cells. Furthermore,
the chemokine also interacts with two receptors, i.e. CXCR4 and CXCR7.
We have identified a high affinity mirror-image oligonucleotide (NOX-A12,
olaptesed pegol) that neutralizes SDF-1's interactions with both receptors.
The compounds showed intriguing efficacy in different oncology models.
Currently, the substance is profiled in two Phase IIa studies in patients with
multiple myeloma and chronic lymphocytic leukemia.
Sven Klussmann, Ph.D., Chief Scientific Officer, NOXXON Pharma AG,
Germany
12:15 Networking Luncheon with Exhibit and Poster Viewing
1:30 DNA/RNA Heteroduplex Oligonucleotide as a Novel
Concept of Therapeutic Oligonucleotide
We develop a short DNA/RNA heteroduplex oligonucleotide (HDO) with a
structure different from double-stranded RNA used for short interfering RNA
and single-stranded DNA used for ASO. A DNA/lockednucleotide acid gapmer
duplex with an a-tocopherol-conjugated complementary RNA (Toc-HDO) is
significantly more potent at reducing the expression of the targeted mRNA in
liver compared with the parent single-stranded gapmer ASO. Toc-HDO also
improves the phenotype in disease models more effectively. In addition, the
high potency of Toc-HDO results in a reduction of liver dysfunction observed
in the parent ASO at a similar silencing effect.
Takanori Yokota, M.D., Ph.D., Professor, Neurology Neurological Science,
Tokyo Medical and Dental University, Japan
2:00 From Concept to Clinic: MRG-106, a
LNA-antimiR® Targeting microRNA-155 for
Hematological Malignancies
microRNA-155 is a product of the bic oncogene and its overexpression has
been implicated as a poor prognostic indicator in a variety of hematological
malignancies. We identified MRG-106 through a rational screening approach
demonstrating target engagement in human cancer cells in vitro via passive
cellular uptake. Additional preclinical studies revealed a favorable PK/PD and
safety profile for the candidate. Our translational development strategy is based
on early mechanistic proof of concept and progressive de-risking in man.
William S. Marshall, Ph.D., President and CEO, miRagen Therapeutics, USA
2:30 Oligonucleotides in Oncology and Conjugation Strategies
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Bob Brown, Ph.D., CSO and SVP, Research, Dicerna Pharmaceuticals, USA
3:00 Networking Refreshment Break with Exhibit and Poster Viewing
11:10 Chairperson’s Remarks
El Djouhar Rekaï, Head of Peptide Products Operation, Lonza, Belgium
11:15 Cystine Knot Peptides asTemplates in Drug Design
Cyclotides are ultra-stable cystine-knot containing peptides that have great
potential as templates in drug design. There are now 15 published examples
of cyclotide-based drug leads for conditions including cancer, cardiovascular
disease, autoimmune disease and pain, amongst others. This presentation will
describe the design strategies and future possibilities for cyclotide-based drug
design. Of particular note is the ability of cyclotides to penetrate cells and
modulate intracellular targets, including protein-protein interactions.
David Craik, Ph.D., Professor of Biomolecular Structure, Institute for
Molecular Bioscience University of Queensland, Australia
11:45 New Broad Activities of CBP501 in Tumor Cells and the
Tumor Microenvironment Uncovered by the Results of
Phase II Clinical Studies
CBP501, a synthetic dodecapeptide, completed two Phase II clinical studies
for malignant pleural mesothelioma and NSCLC. In the NSCLC study, survival
was significantly prolonged in a patient population with normal WBC. These
results led to studies revealing new broad effects of calmodulin modulation by
CBP501 in tumor cells and the tumor microenvironment. CBP501 continues to
hold promise as a drug candidate in the paradigm-shifted immune oncology
drug development world.
Takumi Kawabe, M.D., Ph.D., President CEO, CanBas Co. Ltd., Japan
12:15 Networking Luncheon with Exhibit and Poster Viewing
1:30 Macrocycles Addressing
ChallengingTherapeuticTargets –
An Underexploited Structural Class
Macrocycles provide diverse functionality and stereochemical complexity in a
conformationally pre-organized ring structure. This can result in high affinity
and selectivity for challenging intra- and extracellular protein targets while
preserving excellent bioavailability. Polyphor has developed two proprietary
technologies for the generation of fully synthetic macrocycles for target-
based as well as phenotypic screening. An automated and highly streamlined
medicinal chemistry optimization process to advance initial hits to clinical
candidates in rapid iterative cycles is in place. This presentation will focus on
some representative case studies.
Daniel Obrecht, Ph.D., Chief Scientific Officer, Co-Founder, Polyphor Ltd.,
Switzerland
2:00 Presentation Sponsorship Opportunity
For more information about sponsoring a drug development case study,
application or technology presentation in this session, please contact
Patrick Gallagher at pgallagher@ibcusa.com
Peptide CMC and Analytical Strategies
2:30 Improved Chemical and Physical Stability in Liquid
Formulations – How to Design Stable Glucagon Analogues
Through a series of iterative changes in the native sequence of glucagon
we present an optimized glucagon analogue (ZP-GA-1) suitable for
long term storage as a liquid formulation with a pharmacokinetic and
pharmacodynamic profile of native glucagon. ZP-GA-1 exhibits superior
solubility (25 mg/ml) at neutral pH relative to native glucagon and
improved chemical and physical stability.
Lise Giehm, Ph.D., Senior Scientist, Pharmaceutical Development,
Zealand Pharma A/S, Denmark
3:00 Networking Refreshment Break with Exhibit and Poster Viewing
3:30 CMC Challenges and Large Scale
Manufacturing of Synthetic Peptides
The latest developments in the large scale manufacturing of synthetic
peptides will be presented. The talk will consider CMC challenges, process
development and manufacturing aspects for large scale SPPS and prep.
HPLC purification.
Daniel Samson, Ph.D., Senior Director API Manufacturing, Bachem AG,
Switzerland
Oligonucleotides in Preclinical and
Clinical Development (continued)
Peptide Discovery, Preclinical and Clinical
6. Main Conference • Plenary Session Friday, February 26, 2016
6 To Register, Call: (+65) 6508 2401 • Fax: (+65) 6508 2407 • E-mail: register@ibcasia.com.sg
8:45 Registration and Coffee
9:10 Chairman’s Remarks
Osamu Sato, Executive Director, RD Planning Department, Daiichi Sankyo,
Japan
Keynote Presentation
9:15 Challenge of Daiichi-Sankyo to be a Global
Pharma Innovator: Updated Directions
This presentation will discuss the challenge of Daiichi-
Sankyo to become one of the world’s leading innovators in
pharmaceutical drug business and RD with a diverse drug
portfolio. This talk will give an overview of Daiichi-Sankyo's
strategic business and scientific strategies, including its vision in the field of
oligonucleotide drug development.
Joji Nakayama, Representative Director, President CEO, Daiichi Sankyo,
Japan
Featured Presentation
9:45 Semaglutide, An Acylated GLP-1 Analog
Suitable for Once-Weekly Administration
Following the successful development of the first once-daily
GLP-1 analog liraglutide, we aimed to discover analogs suitable for
once-weekly dosing through acylation with fatty acids enabling
binding to serum albumin in vivo.This technology avoids the need
for substantially increased molecular weight by fusion to a large inactive protein,
or marked additives in the formulation requiring larger needle sizes.The fatty acid
“sidechain”was one of the key features to secure the combination of high albumin
affinity and high GLP-1R potency. Several parameters were investigated such as
length and type of fatty acid as well as the linking chemistry between the fatty acid
and GLP-1. Semaglutide has a peptide backbone with two substitutions compared to
human GLP-1 (8Aib, 34Arg) and is derivatized with a fatty acid“sidechain”at lysine 26.
Semaglutide is in phase 3 clinical trial for treatment of diabetes.
Jesper Lau, Ph.D., Vice President, Diabetes Protein and Peptide Chemistry,
Novo Nordisk A/S, Denmark
10:15 Refreshment Break
10:45 Late Breaking Presentation
Regulatory Perspectives on Oligonucleotide
and Peptide Impurities
11:15 Regulatory Considerations and Challenges on Impurity
Issues during Different Phases of Oligonucleotide and
Peptide Drug Development
Due to their diverse therapeutic activities, peptides and oligonucleotides may
be regulated under different regulations in the US, for example, as chemical
drugs or biological products, with different requirements for each. ICH changes
to the peptide guidance have also made it very challenging for companies to
deal with regulatory issues such as impurities, during the different phases of
development. The presentation will discuss 1) the effects of organization and
process changes in the US on the review and approvals of oligonucleotide and
peptide products, 2) the unique regulatory issues associated with impurities of
oligonucleotides and peptides and 3) common mistakes and how to manage
potential impurity problems during different phases of drug development, for
example, during site scale-up and site changes.
Duu-Gong Wu, Ph.D., Director/Senior Consultant, PPD Regulatory
Consulting and Former Deputy Division Director, Division of New Drug
Chemistry, US FDA/CDER, USA
11:45 Close of AsiaTIDES Main Conference
Main Conference • Concurrent Tracks Thursday, February 25, 2016(continued)
Oligonucleotide CMC and Analytical Strategies
3:30 CMC Case Study
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Alun Garner, Business Development Manager, Nucleic Acid Solutions
Division, Agilent Technologies, Inc.
4:00 Small Scale Manufacturing of Novel Oligonucleotides
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Huihe (Julia) Zhu, Ph.D., Group Leader, Small Scale Oligo Unit,
Nitto Denko Avecia
4:30 GalNac Conjugated LNA Oligonucleotides
This presentation will describe our progress with GalNac conjugated LNA
oligonucleotides. The focus of the presentation will be on CMC studies and
lessons learned, with some in-vivo data also presented.
Christoph Rosenbohm, Ph.D., Senior Director Research Operations,
Roche Innovation Center Copenhagen, Denmark
5:00 Close of Day Two
4:00 Life-cycle Management in Peptide Manufacturing
As technologies for the production of synthetic peptides evolve, the
chemical processes developed and validated 15 or 20 years ago often need
to be optimized for safety, productivity and cost effectiveness. As a leader in
the custom manufacturing of synthetic peptides, Lonza is putting emphasis
on the life-cycle management of its products in an increasingly competitive
environment. This case study of a generic peptide will present the activities
involved to support such a program, including process and analytical
development, process qualification and validation as well as the regulatory
filing strategy. The benefits of such a program will be described, both for the
CMO and for the customer.
Jean-Marc Poudrel, Ph.D., Program Manager, Lonza Braine SA, Belgium
4:30 Development of a Large Scale Process
for the Manufacture of a Small Cyclic
Peptide API
Abstract not available at time of print. Please visit
www.IBCLifeSciences.com/AsiaTIDES for updates.
Jon Holbech Rasmussen, Ph.D., Director Global Development,
PolyPeptide Group, Sweden
5:00 Close of Day Two
Peptide CMC and Analytical Strategies (continued)
Conference Language
The conference will be conducted in English without translation.
Travel/Visa Information
PLEASE NOTE: Visas are required for some nationalities to travel to Japan for this conference. Please
contact your travel agent and/or the Japanese Consulate/Embassy in your country for exact details
and visa application procedures as soon as possible. Visa processing times can vary.
About the Organizers
This event is brought to you by the organizers of the TIDES and EuroTIDES conferences. IBC
Life Sciences, an Informa business, is your connection to the life sciences industry. To see all
of the in-depth content IBC Life Sciences has to offer, visit www.IBCLifeSciences.com.
“AsiaTIDES was extremely productive. The senior players who attended and the intimacy of the conference afforded
many opportunities for networking with current and potential collaborators. It's a great forum if you want to further your
scientific knowledge and meet new partners. – Peter Lutwyche, Ph.D., Arbutus Biopharma Corporation
7. Sponsors and Exhibitors(As of October 2, 2015 , 2015)
Visit www.IBCLifeSciences.com/AsiaTIDES for up-to-date information on this event 7
Post-Conference Workshops Friday, February 26, 2016 • 12:00pm-4:00pm
Workshop #1: Current Status of Oligonucleotide
Drug Delivery Approaches and Systems (DDS)
Workshop Moderator: Dmitry Samarsky, Ph.D., SVP, International Business and
Technology Development, RiboBio, China
RNAi and antisense oligonucleotides promise to become the third major therapeutic
modality (besides small molecules and biologics), offering an opportunity to target
virtually any disease causing gene. Such promise, however, requires addressing the
challenge of delivering oligonucleotide-based therapeutic compounds to the tissues/
organs originating the disorders, as well as inside the cells producing the disease
phenotype. This workshop will dissect the delivery issue into smaller sub-challenges,
review those in deeper detail and offer some examples of successful solutions
Additional topics to be discussed include:
•Why oligos bio-distribute predominantly to a small group of organs (mostly liver)?
• If endothelial barriers prevent from broader bio-distribution, what can be done about it?
• Is tissue/organ penetration an additional challenge/barrier for oligo drug delivery?
• How do oligonucleotides cross cellular membrane barriers?
• Should we consider oligos as a class or individual compounds when it comes
to delivery?
• How big of a factor for choosing delivery approaches is the manufacturing component?
Workshop #2: Peptide Formulations:
Regulatory Considerations for Early Clinical Research
Workshop Moderators:
Christopher A. Rhodes, Ph.D., President and CEO, Drug Delivery Experts
Bruce Morimoto, Ph.D., Executive Director Applied Translational Medicine,
Drug Development Services, Celerion
This workshop will discuss lifecycle strategies for peptides and peptide formulations
from late stage research to early clinical development and beyond. Formulation
challenges of novel and complex peptide structures will be presented along with
dosage form strategies in early stage development and techniques for lifecycle
planning. The workshop will include a detailed case study on buccal delivery of
peptides with an emphasis on the early stage strategies needed to establish feasibility
of the project. Additional peptide case studies from early to late stage development
along with challenges encountered and lessons learned will also be presented.
Additional topics to be discussed include:
• What goes into a US Investigational New Drug (IND) application?
• What research or formulation development work is needed?
• What toxicology work is needed?
• Simple versus complex formulations and delivery options and life-cycle management
12:00 Networking Luncheon for Workshop Attendees
1:00 Workshop Opening Remarks
2:30 Refreshment Break
4:00 Close of Workshop
Post-Conference
Workshop Schedule
Silver Sponsors
Agilent’s Nucleic Acid Solutions Division offers industry
leading experience to efficiently advance your lead oligo
candidates from clinic to market with a common goal of
patient health and safety. With Agilent, you always have peace of mind by partnering with a
company that has the financial resources, stability and vision required for long-term success.
Contact us at: pdl-oulderinfo@agilent.com and find out why the world’s most revolutionary
biotech companies and their Big Pharma partners are choosing Agilent Technologies to
develop and commercialize their oligo APIs.
Bachem specializes in the manufacture of peptides and
complex small molecules as APIs as well as innovative
biochemicals for research purposes. We offer technical
consultancy, comprehensive regulatory affairs support, and dedicated project management
from drug development through commercial scale cGMP production. Headquartered in
Bubendorf, Switzerland with affiliates in Europe and the U.S.
Established in 1981, ChemGenes, an ISO9001 certified
company, has consistently provided the highest quality
Phosphoramidites and Solid Supports in the market and
continues to lead the industry in oligonucleotide reagent manufacturing. Our Massachusetts
facility is setup for Bulk Therapeutic Grade phosphoramidite production for GMP grade
oligonucleotide manufacturing. Additionally, ChemGenes carries the widest variety of
modified phosphoramidites and supports currently used in oligonucleotide synthesis
including Microarray Technology, Oligonucleotide Therapeutics, Oligonucleotide Based
Probes and other areas of Nucleic Acid research. ChemGenes remains devoted to providing
you with invaluable customer service and comprehensive technical support.
Lonza offers the life sciences market a full range of bioresearch
products, development services and manufacturing for active
ingredients. For 30 years we have been helping companies increase product quality, improve
production processes, navigate regulatory hurdles, lower costs, and get to market faster.
From early development to in-market supply, our complete development services,
industry-leading manufacturing processes, broad technology platform and lifecycle
management experience can help take your product to the next level. For flexible,
high-quality manufacturing, development services and products, we can help.
Driven by Excellence, Guided by Experience. When you partner with
Avecia, (www.Avecia.com) you will be working with the leading
oligonucleotide CMO. Avecia offers the most extensive process
validation experience in the oligo industry. As a member of the Nitto
Denko Corporation (www.nitto.com), Avecia is committed to the future of the
oligonucleotide market. We offer our customers oligo manufacturing capacity in two
separate facilities (MA and OH). Our Cincinnati facility also provides expanded pre-clinical
oligo services (OliGROW), as well as small molecule expertise and production. Our aim is to
leverage our wealth of experience, to ensure we exceed our customer’s expectations. Avecia
has the stability and vision required for the long-term success of your oligo program.
The PolyPeptide Group is a leading provider of proprietary
GMP, generic and non-GMP peptides and peptide
conjugates for the pharmaceutical, cosmetic, and biotech
industries as well as basic research. With 6 GMP facilities located across 3 continents, the
Group supports peptide projects at all scales from pre-clinical through to commercialization.
Bronze Sponsors
Polyphor is a Swiss Pharma company focusing on the discovery and
development of macrocycle drugs addressing high unmet medical
needs. These macrocycles represent a new drug class
complementary to the classical small molecules and large biopharmaceuticals. Polyphor`s
proprietary technologies are broadly applicable to a wide array of biological targets and disease
areas and already delivered a rich pipeline of pre-clinical and clinical drug candidates.
Waters Division creates business advantages for laboratory-
dependent organizations by delivering ultra performance liquid
chromatography (UPLC), high performance liquid
chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry
systems, laboratory informatics solutions, and comprehensive service programs to enable
significant advancement in healthcare delivery, environmental management, food safety, and
water quality
GeneDesign specializes in contract development and
manufacturing of oligonucleotides therapeutics and
diagnostics from screening stage to commercial stage.
Session Sponsors
Networking Reception Co-Sponsors
Exhibitors(As of October 2, 2015)
Agilent Technologies Inc
Bachem AG
BCN Peptides S.A.
ChemGenes Corporation
GeneDesign Inc
Hongene Biotechnology Ltd
Kinovate Life Sciences Inc
Lonza
Nitto Avecia
Polypeptide Group
ST Pharm
Connect with 200+ Oligo and Peptide Decision Makers
Reserve Your Exhibit Booth or Sponsorship Today!
• Showcase your latest technology to our targeted audience of key decision-makers
• Build invaluable relationships and form new partnerships that give you a
competitive advantage in the US, Europe and Asia-Pacific
• Gain international exposure through our specialized marketing campaign
Call today to learn about the cost effective ways to drive lead generation and
network with key buyers, including: Turn Key Exhibit Booth Packages, Event
Partner Packages; Spotlight Session and Luncheon Briefing Sponsorships;
Custom Emails, and Meeting Space
For more information on how you can connect with these key
buyers, contact: Patrick Gallagher • Tel: 617-512-6656
Email: pgallagher@ibcusa.com
8. Payment
Payment must be received 10 business days prior to the event.
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Industry Rates SAVE USD400
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by Feb. 5, 2016
Standard Rate
After Feb. 5, 2016
o Main Conference + Workshop* USD 1,899 USD 1,999 USD 2,099 USD 2,199 USD 2,299
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*Select one Post-Conference Workshop:
o Workshop #1: Current Status of Oligonucleotide Drug Delivery Approaches and Systems (DDS)
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Academia/Government Discounts – 40% Savings: Academic and government employees are eligible for over 40%
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affiliated hospitals who have NO affiliation to a for profit entity. See website for details.
Present a Poster o USD125 - Commercial o FREE - Academic
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Please tell us your primary area of interest: o Oligonucleotides o Peptides
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AsiaTIDES – Oligonucleotide and Peptide® Research, Technology and Product Development
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